Safety
RiaSTAP is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products.
The most serious adverse reactions observed are thrombotic episodes (pulmonary embolism, myocardial infarction, deep vein thrombosis, arterial thrombosis) and anaphylactic reactions. The most common adverse reactions observed in clinical studies (frequency >1%) were fever and headache.
Virus Inactivation
RiaSTAP is made from pooled human plasma and thus may contain infectious agents. However, virus inactivation/removal reduces the risk of exposure to infectious agents.
CSL Behring is committed to maintaining the highest standards of quality and safety throughout
the production process. Our
integrated safety system
allows only the highest quality plasma to be selected for use in manufacturing, enabling the release of safe and effective product. Quality control measures, including numerous inspections, tests, and crosschecks, are performed by highly trained personnel at each stage in the manufacturing process.
All potential donors are carefully screened before being allowed to donate plasma. The plasma undergoes thorough serological and biochemical screening of fractionation pools using nucleic acid amplification technology by polymerase chain reaction method to confirm the absence of hepatitis C virus RNA, hepatitis B virus DNA, and human immunodeficiency virus RNA.
| Cumulative (log10) virus inactivation/reduction in RiaSTAP |
| Manufacturing Step |
Virus Reduction Factor (log10) |
| Enveloped Viruses |
Non-enveloped Viruses |
| HIV |
BVDV |
WNV |
PRV |
HAV |
CPV |
B19V* |
| Cryoprecipitation |
n.d. |
n.d. |
n.d. |
1.6† |
n.d. |
1.9 |
n.d. |
| Heat treatment |
≥ 5.7 |
≥ 9.1 |
≥ 8.3 |
5.4 |
5.9 |
1.4 |
≥ 4.5* |
| Glycine precipitation (two subsequent steps) |
3.9 |
2.1 |
n.d. |
1.8 |
1.0‡ |
1.6‡ |
n.d. |
| Lyophilization |
n.d. |
n.d. |
n.d. |
n.d. |
1.7 |
n.d. |
n.d. |
| Cumulative virus reduction (log10) |
≥ 9.6 |
≥ 11.2 |
≥ 8.3 |
8.8 |
8.6 |
4.9 |
≥ 4.5 |
HIV, human immunodeficiency virus;
BVDV, bovine viral diarrhea virus, model for HCV;
WNV, West Nile virus;
PRV, pseudorabies virus;
HAV, hepatitis A virus;
CPV, canine parvovirus, model for B19V;
B19V, human parvovirus B19.
*The virus elimination studies for parvovirus B19 employed a novel experimental infectivity
assay utilizing clone of cell line UT7 that contains erythropoietic progeny cells. Virus titer was
determined using an immunofluorescence-based detection method; †PRV is reduced
by cryoprecipitation by 1.6 log10; ‡Not included in the calculation of the cumulative virus reduction
factor; n.d., not determined.
Learn about the
efficacy of RiaSTAP
Learn about
RiaSTAP: Dosing and Administration.
Important Safety Information
RiaSTAP®, Fibrinogen Concentrate (Human), is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products.
Monitor patients for early signs of anaphylaxis or hypersensitivity reactions and if necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving RiaSTAP; weigh the benefits of administration versus the risks of thrombosis.
RiaSTAP is made from human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.
The most serious adverse reactions observed are thrombotic episodes (pulmonary embolism, myocardial infarction, deep vein thrombosis) and anaphylactic reactions. The most common adverse reactions observed in clinical studies (frequency >1%) were fever and headache.
Indications
RIASTAP is indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
Please see full prescribing information for RiaSTAP.
To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
